510(k) Report

FDA applicant

Fissiontech, LLC

New York, NY3 decisions2024–20250 recalls

FDA records 3 decisions for Fissiontech, LLC (New York, NY) from 2024 to 2025: 3 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Fissiontech, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2024: 12025: 2
2024high 2 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Fissiontech, LLC by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LRKDevice, Anti-Snoring3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 78 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K233850Difiney Anti Snoring DeviceFissiontech, LLC · 20242cite it
  • K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech, LLC · 20251cites it

What has FDA decided for it lately?

  • K253355Difiney Advanced Anti Snoring Device 4.0Fissiontech, LLC · 2025
  • K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueFissiontech, LLC · 2025
  • K233850Difiney Anti Snoring DeviceFissiontech, LLC · 2024

All 3 as Fissiontech, LLC →